(42 days)
The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.
The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.
The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200.
The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table:
| Patient Size (AAPM group) | Weight (Kg) | CTDI (mGy) | SpotLight / SpotLight Duo - Indication for Use |
|---|---|---|---|
| Small | 50-70 Kg | 0.25-2.8 mGy | Proposed Device |
| Medium | 70-90 Kg | 0.5-4.3 mGy | K241200 |
| Large | 90-120 Kg | 1.0-5.6 mGy | K241200 |
There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.
The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).
This FDA 510(k) clearance letter describes the acceptance criteria and study proving the SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (specifically for small patients) meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on image quality and nodule detectability being maintained at low dose levels, specifically for small patients (50-70 kg) within the AAPM guidelines for CTDI. The reported performance confirms these criteria are met.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Quality & Nodule Detectability for Small Patients | |
| Maintenance of diagnostic image quality for Low Dose CT Lung Cancer Screening (LCS) in small patients (50-70kg, |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.